Quality Management System Specialist

Overview

We offer an interesting opportunity to join our Quality team, based in Bussolengo (VR) as Quality Management System Specialist, reporting to the Quality Management System Manager, on a full-time permanent contract. The person is part of the Quality Team and contributes to maintaining the live and compliant Quality Management System implemented in European Subsidiaries. The QMSS aims to ensure that the Quality System conforms with all reference standards and regulatory requirements (ISO 13485, 21 CFR 820) and that supplied products are fit for their purpose and meet customer expectations. QMSS coordinates the activities required to fulfill this aim and monitors and reports on how the quality management system is performing, publishing data and reports regarding company performance against set indicators. QMSS liaises with managers and staff internally to ensure the proper functioning of the Quality system. Where appropriate, the QMSS reports on amendments, implements changes, and provides training, tools and techniques to ensure that quality standards are maintained and can be achieved by all competent staff. As maintaining quality demands continuously adapting to meet customer expectations, the QMSS must place quality assurance at the heart of responsibilities within the Company.

Responsibilities

• Support QMS manager to ensure the maintenance of Quality Management System in compliance with applicable standards.
• Manage the compliance of the training program.
• Perform or assist in performing internal audits.
• Ensure the maintenance of Quality Management System in European Subsidiaries.
• Support QMS manager to ensure that all Company processes are designed and executed according to policies, predetermined internal procedures and international applicable standards such as MDD, MDR, FDA or those of other Bodies.
• Implement Best Practices and plan for continuous Quality System improvements projects with specific deployed tasks.
• Maintain the adequacy of QMS Procedures and Operative Procedures, and ensure these are observed by all employees in the designated Group Companies.
• Support QMS manager to define and document Quality specifications.
• Provide inter-functional support to implement and formalize design changes and other Quality modifications in the Organization.
• Ensure the maintenance of controlled documents for their full lifecycle and coordinate the management of product modifications in cooperation with the Organization.
• Ensure quality trainings on new hires and for trainable documents.
• Support QMS manager to address third party audits.
• Support QMS manager to collect, evaluate and analyze Quality records.
• Report periodically to management on quality issues, trends and losses.
• Evaluate the Quality results achieved and notify the QMS manager of any incompatibility with company objectives.
• Cooperate with regulatory affairs in the preparation and maintenance of adequate regulatory documents and certifications relevant to medical devices manufactured by Orthofix and/or placed on the marketplace under QS control (e.g., OEM business).
• Promote internal training on quality matters in cooperation with all other functions.
• Promote and participate in continuous (breakthrough) processes.
• Support QMS manager to develop and implement Quality Policies and procedures with regards to the definition of the International applicable standard.

What are we looking for?

• Preferred technical degree or master’s degree.
• 2 years in similar positions, in multinational companies preferably operating in the Medical Device field.
• Internal auditor qualification welcome.
• Excellent English written and spoken required.
• Good knowledge of Microsoft Office and with analysis and reporting tools.
• Soft skills: ability to work precisely according to procedures, adherence to timelines and result-oriented attitude, orderliness and attention to detail, analytical approach to resolve complex issues, ability to work in team and autonomously, accountability for the assigned tasks.

What will you find?

• Friendly, warm, and innovative atmosphere.
• Healthy, inspiring, international and inclusive work environment.
• Training and development opportunities.
• Smart working model (two days per week).
• Competitive reward packages.
• Social and company events.
• Wellbeing initiatives (welfare).
• Canteen benefits (Pension Fund - Health Insurance).

What we offer?

This is a full-time job. The contract is a permanent contract.

Salary package range: 35.000 / 40.000 euro

• Please note that this is a range.
• The complete salary package will be defined based on the seniority / skills of the person.

Do you want to join us? Are you ready to make a difference?